We are seeking a Quality Reviewer – Pharmacovigilance to join our team in Noida. This is an on-site role for professionals with experience in ICSR case reviews using Argus Safety.
Key Responsibilities:
- Conduct quality reviews of Individual Case Safety Reports (ICSRs) in Argus Safety Database.
- Ensure compliance with pharmacovigilance regulations (FDA, EMA, ICH-GCP).
- Perform data accuracy checks, consistency reviews, and compliance audits.
- Collaborate with pharmacovigilance teams to resolve discrepancies.
- Maintain SOPs (Standard Operating Procedures) and ensure adherence to timelines.
- Support regulatory inspections and audits as needed.
Eligibility Criteria:
- Education: M.Pharm / B.Pharm / BDS / PharmD
- Experience: Minimum 2 years in ICSR Quality Review (Argus Safety)
- Strong knowledge of MedDRA, WHO-DD, and pharmacovigilance guidelines
- Excellent attention to detail and analytical skills
About Soterius (Pharmabharat.com)
Soterius is a leading name in pharmacovigilance and regulatory compliance, providing end-to-end drug safety solutions. Through Pharmabharat.com, we connect top talent with leading pharmaceutical and healthcare organizations.
How to Apply?
If you meet the criteria, send your updated resume to:
📩 hr@soterius.com
🔹 Job Location: Noida (Work from Office)
🔹 Openings: 4
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